BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM

    MDR report key: 1771420 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12568
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    November 26, 2009
    Report Date
    June 10, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE DECLARED END OF LIFE DUE TO LONG CHARGE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1852

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 1852| 0157